A BRIEF REVIEW ON PROCESS ANALYTICAL TECHNOLOGY (PAT)
Keywords:
PAT, Pharmaceutical, Manufacturing process, Quality assuranceAbstract
Process analytical technology (PAT) has been defined as a mechanism to design, analyze and control pharmaceutical manufacturing processes through measurement of critical process parameters which affect critical quality attributes. PAT checks the quality of raw material attributes both physically and chemically (i.e. at off-line, on-line, in-line). PAT involves a shift from testing the quality of building to the quality of products by testing at several intermediate steps. PAT saves a huge amount of time and money required for sampling and analysis of products. The main goal of PAT is to provide successful tools such as multivariate data analysis and acquisition tools, modern process analyzers or analytical chemistry, endpoint process monitoring, controlling tools and continuous improvement and knowledge improvement tools. In this review attempt has been carried out to explore the concept of PAT, different tools of PAT, goals of PAT, How it Works and Its benefits.
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References
Rakshit V Thumar, Vidhi N Kalola, Nishendu P Nadpara, Parula B Patel. A complete review of process analytical technology. Int J Pharm Sci Rev Res 2012;17;57-65.
Bakeev KA. Near-infrared spectroscopy as a process analytical tool. Part II. Atline and on-line applications and implementation strategies. Spectroscopy 2004;19:39–42.
http://www.fda.gov. [Last accessed on 10 Oct 2015].
FDA. Pharmaceutical cGMP for the. 21st. Century–A risk-based approach; Final report; 2004. p. 1-3.
Jaydeep Ganguly, Gerrit Vogel. 'Process analytical technology. J Int Soc Pharm Eng 2006;26:1-9.
Mowery MD, Sing R, Kirsch J, Razaghi A, Béchard S, Reed RA. Rapid at-line analysis of coating thickness and uniformity using laser-induced breakdown spectroscopy. Pharm Biomed Anal 2002;28:935-43.
Kaiser HF. The application of electronic computers to factor analysis. Educ Psychol Meas 1960;20:141-51.
Goal for process analytical technology visit. Available from: http://www.fda.gov/cder/OPS/PAT.html. [Last accessed on 09 Aug 2012].
Zackrisson G, Ostling G, Skagerberg B, Anfalt T. Accelerated dissolution rate analysis (ACDRA) for controlled release drugs application to roxiam. J Pharm Biomed Anal 1995;13:377-83.
Validation of pharmaceutical process. 3rd. Edition by James. Agalloco, Frederic J Carleton; 1925. p. 585-93.
Everything You Need to Know about Process Analytical Technology (PAT) Implementations, Thermo scientific paper, Thermo Fischer Scientific Inc. UK; 2006. p. 14.
Office of Pharmaceutical Science (OPS), Process analytical Technology (PAT) Initiative, FDA, US; 2005.
Inspections-Process analytical Technology, EMEA requirements; 2008.
Katherine A. (EDT) Bakeev, Process Analytical Technology; 2006. p. 329-32.
Kirsch J, Drennen J. Determination of film coated tablet parameters by near infrared spectroscopy. J Pharm Biomed Anal 1995;13:1273-81.
Lim KC, Hashim MA, Gupta BS. In: Mixing and Crystallization; Gupta BS, Ibrahim S. Eds. Kluwer Academic Publishers: Netherlands; 2000. p. 317-28.
Albano CR, Randers-Eichhorn L, Bentley WE, Rao G. Green fluorescent protein as a real time quantitative reporter of heterologous protein production. Biotechnol Prog 1998;14:351-4.
U.S. FDA–Guidance for Industry (draft): Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls and Documentation; 2000. p. 1-17.
Aber Instruments. Viable biomass probes for disposable bioreactors. Press Release; 2008. Available from: http://www. aber-instruments.co.uk. [Last accessed on 15 Sep 2012].